Execution authority: Medical Appliances Safety Supervision Division of Shanghai Food and Drug Administration

Application procedure:
Execution procedur: (I) Procedure for application for establishment
(1) The applicant for establishment of a medical appliances producing enterprise shall submit a written application and following documents (one copy for each):
a. "Application Form for Establishment of Medical Appliances Producing Enterprise in Shanghai";
b. Copy of "Notification on Approval of Preselected Enterprise Name" issued by the authority for industry and commerce;
c. Copy of ID card of the legal representative, the partner or the investor of the enterprise to be established (however the original copy must be checked visually);
d. Copy of certificate of production place (house ownership right or lease intent agreement) (however the original copy must be checked visually);
e. Copy of relevant joint investment contract or agreement, and articles of association, if needed, (however the original copy must be checked visually);
(2) Shanghai Food and Drug Administration shall review the application for establishment since receiving the complete application materials, verify the type of enterprise and make decision whether to approve the application within 15 working days, issuing "Notification on Approval of Establishment of Medical Appliances Producing Enterprise" to the qualified applicant or notifying the unqualified of the reasons for rejection in written form. The applicant shall obtain the business license from the authority for industry and commerce only after it get the "Notification on Approval of Establishment of Medical Appliances Producing Enterprise".

2. Application for license
(1) After obtaining the business license issued by the authority for industry and commerce and finishing the project preparation, the applicant shall apply to Shanghai Drug Administration for "License of Medical Appliances Producing Enterprise" or "Registration Form of Medical Appliances Producing Enterprise" and following documents (one copy for each):

a. "Application Form for License (Registration) of Medical Appliances Producing Enterprise";
b. Copy of business license that is officially registered at the authority for industry and commerce, (with official seal);
c. Copy of "Notification on Approval of Establishment of Medical Appliances Producing Enterprise";
d. Copy of certificate of production place (house ownership certificate and/or lease agreement) (the lessee shall show the house ownership certificate of the lessor) (however the original copy must be checked visually);
e. Registered product standard of Type 1 and 2 products verified by Shanghai Drug Administration or the registered product standard of Type 3 product approved by the primary examination;
f. Copy of qualification certificate and training certificate of staff;
g. Verification conclusion and test record of operation of production and inspection equipments (legal proof shall be provided to the products with special requirement);
h. Copy of inspection report of production environment for the abactcrial medical appliances, when required;

i. Documents of quality assurance system or catalogue of quality management system.
(2) Shanghai Drug Administration shall review the application materials as per relevant regulations within 30 working days since accepting the application for license and registration of medical appliance producing enterprise and examine the production site. The conclusions of site examination are of two types: A and B of comprehensive score mean "Site Examination Qualified" and C of comprehensive score means "Site Examination Unqualified". The Administration shall issue "License of Medical Appliances Producing Enterprise" to the applicant that is a Type 2 or Type 3 medical appliances producing enterprise and qualified to both material review and site examination, or "Registration Form of Medical Appliances Producing Enterprise" to the applicant that is capable of the production of Type 1 medical appliances. For the applicant unqualified, the Administration shall issue a notification of termination of examination and explain the reasons.

3. Application for certificate replacement
(1) The medical appliances producing enterprise shall apply to Shanghai Drug Administration for replaement of the "License of Medical Appliances Producing Enterprise" that is used only for registration of products by the "License of Medical Appliances Producing Enterprise" with normal period of validity, after finishing the registration of products, and submit following documents (one for each):

a. "Application Form of Shanghai for Replacement of Certificate of Medical Appliances Producing Enterprise";
b. Relevant certification documents for replacement and copy of product registration certificate;
c. Original and duplicate copy of "Linces of Medical Appliances Producing Enterprise".
(2) Shanghai Drug Administration shall make a decision whether to approve the application for replacement of certificate within 20 working days since receiving the complete application materials for replacement, issuing the "License of Medical Appliances Producing Enterprise" with normal period of validity to the qualified, or notifying the unqualified of the reasons for rejection in written form.
Standard and basis of charge: 1. 600 yuan for every "License of Medical Appliances Producing Enterprise" (engaged in Type 2 and/or Type 3 products).

2. 300 yuan for every "Registration Form of Medical Appliances Producing Enterprise" (engaged in Type 1 products).

Submitted to:
Execution address: Shanghai Examination Center for Drugs and Medical Appliances, 1399 Huashan Road, Shanghai

audituser：

Basis of execution: 1. Article 19 and 20 of "Regulations on Supervision and Management of Medical Appliances", No. 276 Decree of State Council;

2. "Measures on Administration of Medical Appliances Producing Enterprises", No. 18 Decree of State Food and Drug Administration.

3. "Notification on Issuance of 'Detailed Rules of Shanghai on Implementation of Approval and Registration of Medical Appliances Producing Enterprises'", No. HUYAOJIAN (2002) 349, issued by Shanghai Food and Drug Administration.

4. "Reply of Agreement on Charging for the Review of License of Medical Appliances Producing and Trade Enterprise", No. HUCAIZONG (2000) 46 and No. HUJIAHANG (2000) 158, issued by Shanghai Finance Bureau and Shanghai Price Bureau.

Contact phone: 021-62837766-811/812/813

Website:
Duration of service: 9:00-11:30 am and 1:00-4:30 pm every Monday to Thursday; 9:00-11:30 every Friday

Time limit:
Applicant's qualification: Scope of application:

Application for establishment of Type 1 medical appliances producing enterprise and the "Registration Form for Medical Appliances Producing Enterprise" and the application for establishment of Type 2 or Type 3 medical appliances producing enterprise and the "License of Medical Appliances Producing Enterprise".

Preconditions of applicant:

(1) Professional technicians suitable to the medical appliances to be produced;

(2) Proper places and environment for production and storage of the medical appliances to be produced;

(3) Suitabe production equipment for the medical appliances to be produced;

(4) Qualified quality inspection department or staff and inspection equipment for the medical appliances to be produced;

(5) Quality assurance system or quality management system;